Author name: Leonardo Arias

New FDA draft guidance doubles down on expediting approvals of personalized gene therapies

The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for Medicare & Medicaid Services has revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products.

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Data leak kickstarts ESMO, BMS reports autoimmune CAR T death, pharma M&A outpaces 2025

Merck stole the show at the European Society for Medical Oncology (ESMO) annual conference, with new data on its Moderna-partnered personalized cancer vaccine leaking prior to the presentation and antibody-drug conjugate sac-TMT making a splash in endometrial cancer; Bristol Myers Squibb revealed the death of a patient with multiple sclerosis in an early-stage trial of

Data leak kickstarts ESMO, BMS reports autoimmune CAR T death, pharma M&A outpaces 2025 Read More »

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